East Walpole, United States
almost 2 years ago
This is an individual contributor position that requires an individual with knowledge/experience of writing operational procedures in a regulated environment, e.g., IVD, Medical Device, Pharma, Biotech, etc. The individual in this role will be responsible for writing, reviewing, verifying operational procedures to be implemented in the newly established China manufacturing facility. This position is based in Walpole, MA and reports into the China expansion Documentation Workstream Lead, also based in Walpole.
In this role the individual will be responsible for writing, reviewing, verifying operational procedures to be implemented in the newly established China manufacturing facility.
Specific responsibilities include:
- Verify translated Chinese documents against original English documents to ensure translation accuracy.
- Maintain a comprehensive library of technical terminology and documentation.
- Review, edit and format documents to ensure compliance with GDP and formatting requirements.
- Organize document source files and compile document metadata information to load documents through bulkload process.
- Work with IT and China documentation specialist to manage document bulkload and manual upload process.
- Create BOM and routings for the new Shanghai facility.
- Update reference list for each document using document naming convention master list.
- Assist other team members to coordinate document update activities with all project functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc.
- Assist other team members to coordinate translation activities with Global Translation Agency.
- Assist in compiling KPI data to provide weekly/monthly/quarterly status report to management
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 1 years in an FDA regulated environment, (e.g., IVD, Medical Device, Pharma, Biotech, etc.)
Education: A minimum of a 4 year college degree is preferred, although a combination of education/experience will be considered.
- Fluency in Chinese (Mandarin, simplified) and be able to read/write technical documents in Chinese.
- Prior experience working in an FDA regulated environment and a thorough understanding of good documentation practices.
- Advanced expertise in MS Office Suite, including Excel, Word, Powerpoint.
- Prioritization, attention to details, multitasking, organizational skills, timeline driven and self-motivated
- Ability to apply deductive reasoning and understand complicated issues.
- Must be able to work collaboratively with other project team members.
- Administrative experience with scanning, filing and organization
- Accurately file and maintain the latest physical and electronic copies of all company documentation in accordance with regulations.
Preferred Knowledge/Skills, Education, and Experience
- Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.
- Proven experience working in a technical writing position.
- Project management experience is a plus.